Cutibacterium Acnes ContaminationNCT06379919
Wound Irrigation Comparative Effectiveness Study
A study testing Irrisept Irrigation and Saline Irrigation Solution Delivery in people with Cutibacterium Acnes Contamination, run by Orthopaedic Education and Research Institute (dba Hoag Orthopedics) at 1 site in United States.
Trial summary
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutibacterium Acnes Contamination
- What is being tested?
- Irrisept Irrigation and Saline Irrigation Solution Delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ault patients requiring Total Shoulder Arthroplasty
Who cannot join
- Age younger than 18 years
- History of shoulder infection
- Antibiotic therapy within 2 weeks of surgery
- Cortisone infiltration within 3 months prior to surgery
- Allergy to CHG
- Diagnosis of rheumatoid arthritis
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hoag Orthopedics
Orange, California, 92868
Edward Quilligan, BS, 949-526-1570, Edward.quilligan@hoagorthopedics.org
Kalyn Smith, BS, (949) 526-1570, kalyn.smith@hoagorthopedics.org
About this study
Official title: Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.
- Conditions
- Cutibacterium Acnes Contamination
- Being tested
- Irrisept Irrigation, Saline Irrigation Solution Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisept IrrigationProcedure or surgery
Also called Chlorohexidine Gluconate Solution Delivery
Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
Saline Irrigation Solution DeliveryProcedure or surgery
Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Irrigation Arm (Group 1) | Active comparator | After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points. Receives: Procedure: Saline Irrigation Solution Delivery |
| Irrisept irrigation Arm (Group 2) | Active comparator | After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points. Receives: Procedure: Irrisept Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Acnes Presence
The primary outcome of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2)rimary objecti
Measured: Cultures take during surgery and analyzed over 21 days post surgery
Secondary outcomes (2)
American Shoulder and Elbow Surgeons Patient Reported Outcome Measure
This assessment consists of 17, multiple choice questions that pertain to pain and function of the operated shoulder.
Measured: Pre-operation, 3, 6, 12, & 24 Months post-operation,
Shoulder Range of Motion (ROM)
Shoulder Range of Motion will require the Investigator or Designee to evaluate the following degrees of freedom:
Forward flexion
External Rotation with elbow at side
External Rotation with elbow at 900
Internal Rotation as measured by spinal segment reached.
Measured: Pre-operation, 3, 6, 12, & 24 Months post-operation,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start20 Mar 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cutibacterium Acnes ContaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor
- Investigators
- Hafiz F Kassam, MD, Principal investigator, Hoag Orthopedics Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379919
- Sponsor's protocol ID
- C Acnes in TSA
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg. 2007 May-Jun;16(3):306-11. doi: 10.1016/j.jse.2006.05.013. Epub 2007 Feb 22.
PubMed 17321157Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008.
PubMed 25979553Foster AL, Cutbush K, Ezure Y, Schuetz MA, Crawford R, Paterson DL. Cutibacterium acnes in shoulder surgery: a scoping review of strategies for prevention, diagnosis, and treatment. J Shoulder Elbow Surg. 2021 Jun;30(6):1410-1422. doi: 10.1016/j.jse.2020.11.011. Epub 2020 Dec 26.
PubMed 33373684Chuang MJ, Jancosko JJ, Mendoza V, Nottage WM. The Incidence of Propionibacterium acnes in Shoulder Arthroscopy. Arthroscopy. 2015 Sep;31(9):1702-7. doi: 10.1016/j.arthro.2015.01.029. Epub 2015 Mar 29.
PubMed 25823673Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
PubMed 28479255Millett PJ, Yen YM, Price CS, Horan MP, van der Meijden OA, Elser F. Propionibacterium acnes infection as an occult cause of postoperative shoulder pain: a case series. Clin Orthop Relat Res. 2011 Oct;469(10):2824-30. doi: 10.1007/s11999-011-1767-4. Epub 2011 Jan 15.
PubMed 21240577Contreras ES, Frantz TL, Bishop JY, Cvetanovich GL. Periprosthetic Infection After Reverse Shoulder Arthroplasty: a Review. Curr Rev Musculoskelet Med. 2020 Dec;13(6):757-768. doi: 10.1007/s12178-020-09670-8.
PubMed 32827305Cooper ME, Trivedi NN, Sivasundaram L, Karns MR, Voos JE, Gillespie RJ. Diagnosis and Management of Periprosthetic Joint Infection After Shoulder Arthroplasty. JBJS Rev. 2019 Jul;7(7):e3. doi: 10.2106/JBJS.RVW.18.00152. No abstract available.
PubMed 31291202Lemmens L, Geelen H, Depypere M, De Munter P, Verhaegen F, Zimmerli W, Nijs S, Debeer P, Metsemakers WJ. Management of periprosthetic infection after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2021 Nov;30(11):2514-2522. doi: 10.1016/j.jse.2021.04.014. Epub 2021 Apr 22.
PubMed 33895302Horneff JG, Hsu JE, Huffman GR. Propionibacterium acnes infections in shoulder surgery. Orthop Clin North Am. 2014 Oct;45(4):515-21. doi: 10.1016/j.ocl.2014.06.004. Epub 2014 Jul 11.
PubMed 25199422Heckmann N, Heidari KS, Jalali O, Weber AE, She R, Omid R, Vangsness CT, Rick Hatch GF 3rd. Cutibacterium acnes persists despite topical clindamycin and benzoyl peroxide. J Shoulder Elbow Surg. 2019 Dec;28(12):2279-2283. doi: 10.1016/j.jse.2019.06.016. Epub 2019 Aug 27.
PubMed 31471244Phadnis J, Gordon D, Krishnan J, Bain GI. Frequent isolation of Propionibacterium acnes from the shoulder dermis despite skin preparation and prophylactic antibiotics. J Shoulder Elbow Surg. 2016 Feb;25(2):304-10. doi: 10.1016/j.jse.2015.08.002. Epub 2015 Oct 9.
PubMed 26456428McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999 Jan;12(1):147-79. doi: 10.1128/CMR.12.1.147.
PubMed 9880479Edmiston CE Jr, Bruden B, Rucinski MC, Henen C, Graham MB, Lewis BL. Reducing the risk of surgical site infections: does chlorhexidine gluconate provide a risk reduction benefit? Am J Infect Control. 2013 May;41(5 Suppl):S49-55. doi: 10.1016/j.ajic.2012.10.030.
PubMed 23622749Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.
PubMed 27869623
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06379919
- Acronym / sponsor ID
- C Acnes in TSA
- Conditions
- Cutibacterium Acnes Contamination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Orthopaedic Education and Research Institute (dba Hoag Orthopedics)University, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Irrigation Arm (Group 1) | Active comparator | Procedure: Saline Irrigation Solution DeliveryAfter deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points. |
| Irrisept irrigation Arm (Group 2) | Active comparator | Procedure: Irrisept IrrigationAfter deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ault patients requiring Total Shoulder Arthroplasty
Key exclusion criteria (7 listed)
- Age younger than 18 years
- History of shoulder infection
- Antibiotic therapy within 2 weeks of surgery
- Cortisone infiltration within 3 months prior to surgery
- Allergy to CHG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrisept IrrigationAlso: Chlorohexidine Gluconate Solution DeliveryIrrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. | Procedure or surgery | Irrisept irrigation Arm (Group 2) |
| Saline Irrigation Solution DeliveryNormal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors. | Procedure or surgery | Normal Saline Irrigation Arm (Group 1) |
Primary outcome
C Acnes Presence
Time frame: Cultures take during surgery and analyzed over 21 days post surgery
The primary outcome of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2)rimary objecti
2 secondary outcomes
American Shoulder and Elbow Surgeons Patient Reported Outcome Measure
Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,
Shoulder Range of Motion (ROM)
Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 17321157Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg. 2007 May-Jun;16(3):306-11. doi: 10.1016/j.jse.2006.05.013. Epub 2007 Feb 22.
- Background: PubMed 25979553Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008.
- Background: PubMed 33373684Foster AL, Cutbush K, Ezure Y, Schuetz MA, Crawford R, Paterson DL. Cutibacterium acnes in shoulder surgery: a scoping review of strategies for prevention, diagnosis, and treatment. J Shoulder Elbow Surg. 2021 Jun;30(6):1410-1422. doi: 10.1016/j.jse.2020.11.011. Epub 2020 Dec 26.
- Background: PubMed 25823673Chuang MJ, Jancosko JJ, Mendoza V, Nottage WM. The Incidence of Propionibacterium acnes in Shoulder Arthroscopy. Arthroscopy. 2015 Sep;31(9):1702-7. doi: 10.1016/j.arthro.2015.01.029. Epub 2015 Mar 29.
- Background: PubMed 28479255Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
- Background: PubMed 21240577Millett PJ, Yen YM, Price CS, Horan MP, van der Meijden OA, Elser F. Propionibacterium acnes infection as an occult cause of postoperative shoulder pain: a case series. Clin Orthop Relat Res. 2011 Oct;469(10):2824-30. doi: 10.1007/s11999-011-1767-4. Epub 2011 Jan 15.
- Background: PubMed 32827305Contreras ES, Frantz TL, Bishop JY, Cvetanovich GL. Periprosthetic Infection After Reverse Shoulder Arthroplasty: a Review. Curr Rev Musculoskelet Med. 2020 Dec;13(6):757-768. doi: 10.1007/s12178-020-09670-8.
- Background: PubMed 31291202Cooper ME, Trivedi NN, Sivasundaram L, Karns MR, Voos JE, Gillespie RJ. Diagnosis and Management of Periprosthetic Joint Infection After Shoulder Arthroplasty. JBJS Rev. 2019 Jul;7(7):e3. doi: 10.2106/JBJS.RVW.18.00152. No abstract available.
- Background: PubMed 33895302Lemmens L, Geelen H, Depypere M, De Munter P, Verhaegen F, Zimmerli W, Nijs S, Debeer P, Metsemakers WJ. Management of periprosthetic infection after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2021 Nov;30(11):2514-2522. doi: 10.1016/j.jse.2021.04.014. Epub 2021 Apr 22.
- Background: PubMed 25199422Horneff JG, Hsu JE, Huffman GR. Propionibacterium acnes infections in shoulder surgery. Orthop Clin North Am. 2014 Oct;45(4):515-21. doi: 10.1016/j.ocl.2014.06.004. Epub 2014 Jul 11.
- Background: PubMed 31471244Heckmann N, Heidari KS, Jalali O, Weber AE, She R, Omid R, Vangsness CT, Rick Hatch GF 3rd. Cutibacterium acnes persists despite topical clindamycin and benzoyl peroxide. J Shoulder Elbow Surg. 2019 Dec;28(12):2279-2283. doi: 10.1016/j.jse.2019.06.016. Epub 2019 Aug 27.
- Background: PubMed 26456428Phadnis J, Gordon D, Krishnan J, Bain GI. Frequent isolation of Propionibacterium acnes from the shoulder dermis despite skin preparation and prophylactic antibiotics. J Shoulder Elbow Surg. 2016 Feb;25(2):304-10. doi: 10.1016/j.jse.2015.08.002. Epub 2015 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hafiz F Kassam, MD principal investigator
Hoag Orthopedics Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept Irrigation and Saline Irrigation Solution Delivery in people with Cutibacterium Acnes Contamination, run by Orthopaedic Education and Research Institute (dba Hoag Orthopedics) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vance Gardner, MD ((949) 526-1570, anabaino77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Acnes Presence (time frame: Cultures take during surgery and analyzed over 21 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379919, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.